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QA Specialist
QA SpecialistQIAGEN Gruppe • Barcelona, Cataluña, España
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QA Specialist

QA Specialist

QIAGEN Gruppe • Barcelona, Cataluña, España
Hace más de 30 días
Descripción del trabajo

At QIAGEN, we are driven by a simple but powerful vision : making improvements in life possible.

We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.

We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.

At QIAGEN, every day is an opportunity to make a real-life impact.

Join us, grow with us, and together, let's shape the future of biological discovery.

Position Description

QIAGEN is currently searching for a professional to join the QMS Team within the Quality Assurance department in our Barcelona site. This role is a key part of the Operative team and the site, which produces highly complex solutions for infectious diseases detection (IVD Medical Device products).

The role will allow the candidate to show and expand their capacity to both work in teams and also perform autonomous analytical work.

Key responsibilities :

  • Ensure the correct implementation, application, and compliance of all applicable standards (ISO13485, 21CFR820, MDSAP or others) as well as internal Standard Operating Procedures (SOP).
  • Perform job functions in accordance with all applicable standards Operating Procedures (SOP), local and state laws, health & safety guidelines, health authority regulations, and departmental processes.
  • Management, storage, and control of quality system documentation, as well as product and process changes.
  • Act as internal auditor, plan / perform internal audits, create reports and support the establishment of action plans based on nonconformities identified.
  • Write, review, and maintain quality systems documentation.
  • Support regulatory and customer audits.

Position Requirements

  • Degree and / or post graduated qualification in Life Science or Engineering
  • Minimum 2 years of experience working in Quality or similar role in a regulated environment (Medical Device or Pharma are preferred, but also Cosmetics, Food or others can be considered..).
  • Experience participating on the release process in a key role (QA shop floor / Operations, QC, Manufacturing,…) for more than 1 year (advantageous).
  • Experienced working with MS Office.
  • Fluent in Spanish and English, and ideally Catalan.
  • What we offer

  • Meal voucher
  • Health Insurance (conditional to your role)
  • Bonus / Commission
  • Referral Program
  • Employee Assistance Program and internal QIAGEN communities
  • Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve.We inspire with our leadership and make an impact with our actions.We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.

    QIAGEN is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

    Job ID

    EMEA05231

    Country

    Spain

    Location(s)

    Barcelona

    Department

    QA / QC / Regulatory Affairs

    Employment Type

    Regular Full-Time

    Overview

    At QIAGEN, we are driven by a simple but powerful vision : making improvements in life possible.

    We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.

    We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.

    At QIAGEN, every day is an opportunity to make a real-life impact.

    Join us, grow with us, and together, let's shape the future of biological discovery.

    Position Description

    QIAGEN is currently searching for a professional to join the QMS Team within the Quality Assurance department in our Barcelona site. This role is a key part of the Operative team and the site, which produces highly complex solutions for infectious diseases detection (IVD Medical Device products).

    The role will allow the candidate to show and expand their capacity to both work in teams and also perform autonomous analytical work.

    Key responsibilities :

  • Ensure the correct implementation, application, and compliance of all applicable standards (ISO13485, 21CFR820, MDSAP or others) as well as internal Standard Operating Procedures (SOP).
  • Perform job functions in accordance with all applicable standards Operating Procedures (SOP), local and state laws, health & safety guidelines, health authority regulations, and departmental processes.
  • Management, storage, and control of quality system documentation, as well as product and process changes.
  • Act as internal auditor, plan / perform internal audits, create reports and support the establishment of action plans based on nonconformities identified.
  • Write, review, and maintain quality systems documentation.
  • Support regulatory and customer audits.
  • Position Requirements

  • Degree and / or post graduated qualification in Life Science or Engineering
  • Minimum 2 years of experience working in Quality or similar role in a regulated environment (Medical Device or Pharma are preferred, but also Cosmetics, Food or others can be considered..).
  • Experience participating on the release process in a key role (QA shop floor / Operations, QC, Manufacturing,…) for more than 1 year (advantageous).
  • Experienced working with MS Office.
  • Fluent in Spanish and English, and ideally Catalan.
  • What we offer

  • Meal voucher
  • Health Insurance (conditional to your role)
  • Bonus / Commission
  • Referral Program
  • Employee Assistance Program and internal QIAGEN communities
  • Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve.We inspire with our leadership and make an impact with our actions.We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.

    QIAGEN is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

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